Pipamperone (as the hydrochloride)

Generic name
Pipamperone (as the hydrochloride)
Brand name
ATC Code
N05AD05
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Pipamperone (as the hydrochloride)

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No pharmacokinetic studies have been carried out in children.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Severe agitation and unease
  • Oral
    • 2 years up to 18 years
      • Initial dose: 2 - 6 mg/day in 1 dose In the evening.
      • Maintenance dose: depending on the effect and side effects, the starting dose can be increased weekly by steps of 2-4 mg to approximately 1.2 mg/kg/day in 2 doses. Usually to a mean dose of 40 mg/day.
        • Higher doses may be needed. SmPC describes doses up to 6 mg/kg/day or 120 mg/day.
        • Pipamperone should be prescribed by a child and youth psychiatry specialist. The dosage should be determined individually and the lowest possible dose should be used.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Headaches, agitation, confusion, dizziness, drowsiness.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

NOTE: The 40 mg/ml drops are supplied in a squeezy bottle, so there is a risk that squeezing too hard will administer a squirt rather than drops. Check that the patient/carer is able to give the drops correctly.

Follow up if the use is prolonged because of the potential for effects on the capacity to learn. Caution is needed in cases of a predisposition towards extended QT intervals. Also be aware of the occurrence of tardive dyskinesia and malignant neuroleptic syndrome. Do not increase the dose if akathisia occurs.

Caution should be exercised when there is a predisposition towards QT interval extension (QT syndrome, hypokalaemia or hypomagnesaemia, bradycardia and the use of QT-extending drugs).

During treatment with pipamperone, regular checks should be made for extrapyramidal symptoms and other motor disorders. Extrapyramidal symptoms occurring indicates a risk factor for tardive dyskinesia. Consider discontinuing all antipsychotic drugs if signs and symptoms of tardive dyskinesia appear.

It is sensible to consider new or increased feelings of unease or restlessness in the patient as potentially being akathisia before increasing the dose.

As with other antipsychotics, when using pipamperone you should be aware of the occurrence of what is known as ‘malignant neuroleptic syndrome’, in which hyperthermia, extreme muscle rigidity and autonomic instability are key.

 

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIPSYCHOTICS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Phenothiazines with aliphatic side-chain
N05AA02
Butyrophenone derivatives
N05AD01
Indole derivatives
N05AE05
N05AE04
Diphenylbutylpiperidine derivatives
N05AG02
Diazepines, oxazepines, thiazepines and oxepines
N05AH02
N05AH03
N05AH04
Lithium
N05AN01
Other antipsychotics
N05AX12
N05AX13
N05AX08

References

  1. Ketelaars, C, Antipsychotica, Kenniscentrum-KJP, Geraadpleegd 31 jan 2018
  2. Eumedica, SmPC Dipiperon Sirup (6762307.00.00), 03/2015
  3. Eumedica, SmPC Dipiperon Tabletten (6762307.00.01), 03/2015
  4. Online GL. Gelbe Liste Online, https://www.gelbe-liste.de/, Accessed May 16
  5. Hexal, SmPC Pipamperon HEXAL Saft, 4 mg/ml Lösung zum Einnehmen (56009.00.00), 10/2014
  6. neuraxpharm, SmPC Pipamperon-neuraxpharm 40 mg, 120 mg (Tabletten) (48633.00.00), 09/2015
  7. Kloosterboer, SM et al., Pipamperone Population Pharmacokinetics Related to Effectiveness and Side Effects in Children and Adolescents, Clin Pharmacokinet, 2020, May 11
  8. Eumedica N.V., SmPC Dipeperon druppels (RVG 09964) 14 dec 2018, www.geneesmiddelinformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose